Submitted: 27 January 2020; Revised: 29 January 2020; Accepted: 29 January 2020; Published online first: 25 February 2020
Biological medical products (biologicals) are derived from living cells or organisms. Due to their complex structures and the inherent challenges for manufacturing, a degree of minor variability may exist between different batches of the same product and between original biological and follow-on versions, so-called biosimilars. Thus, when adverse drug reactions (ADRs) occur, it is important to know the precise brand name and batch number of the biological involved.
Several studies have concluded, however, that specific product details are not always provided in ADR reports. Consequently, the aim of this study (UK BIO-TRAC study) was to assess the extent to which biologicals are traceable by brand name and batch number in UK hospital practice and in reports of ADRs submitted by patients and healthcare professionals . We per-formed an online hospital pharmacist survey to capture information on how specific product details are recorded in routine UK hospital practice and assessed the proportion of ADR reports specifying brand name and batch number submitted to the UK national spontaneous reporting database, the Yellow Card Scheme, between 1 January 2009 and 30 September 2017.
In the survey, 61 hospital pharmacists from 40 different National Health Service (NHS) Trusts (representing 23% of the 174 eligible NHS Trusts), reported that systematic brand name recording in routine hospital processes (dispensing and administration) ranged from 91% to 79%. Batch numbers were less routinely recorded, ranging from 38% to 58%. Paper-based recording of product details was more commonly used for recording information in the UK hospital setting. A total of 6,108 electronic ADR reports, submitted to the Yellow Card Scheme for recombinant biologicals, were analysed. We found that 38% of these ADR reports had an identifiable brand name whereas only 15% of these ADR reports contained batch numbers. Brand name and batch number traceability was slightly increased for biologicals for which a biosimilar has been approved, although still only 56% of the ADR reports contained an identifiable brand name. Batch number traceability in electronic ADR reports improved slightly after the implementation of the European Union Pharmacovigilance Legislation in 2012. However, no improvement was observed for brand-name traceability.
We therefore conclude that the Pharmacovigilance Legislation from 2012 to strengthen product identification for biologicals in ADR reports has not yet achieved its objective. The traceability of biologicals in UK clinical practice is not always ensured, particularly for batch numbers. The shortcomings in the recording and tracing of product details, such as batch numbers, in UK clinical practice could partially explain the limited traceability of biologicals found in ADR reports. Education and training on the importance of traceability for biologicals in ADR reporting can further support improving the traceability. The findings from this study are in line with an earlier study from The Netherlands [2, 3]. Further research is needed to evaluate how the use of electronic-based routine recording of detailed product information may help to improve trace-ability in clinical practice and eventually in ADR reporting, and in turn help to build a robust pharmacovigilance system that allows for the timely identification of any manufacturing-related safety issues.
Competing interests: None.
Provenance and peer review: Not commissioned; internally peer reviewed.
Kevin Klein1,2,3, PhD
1Foundation Lygature, 6 Jaarbeursplein, NL-3521 AL Utrecht, The Netherlands
2Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, 99 Universiteitsweg, NL-3584 CG Utrecht, The Netherlands
3Exon Consultancy, Amsterdam, The Netherlands
1. Klein K. Hazell l, Stolk P, Shakir S. The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK. Drug Saf. 2019. doi.org/10.1007/s40264-019-00891-6
2. Klein K, Scholl JHG, Vermeer NS, Broekmans AW. Traceability of biologics in The Netherlands: an analysis of information-recording systems in clinical practice and spontaneous ADR reports. Drug Saf. 2016;39:185.
3. GaBI Online – Generics and Biosimilars Initiative. Pharmacovigilance for biologicals in The Netherlands [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 27]. Available from:
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